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The Biotech Directive: ECJ stems the tide of ambiguous rulings on patents

Since our last update, the European Court of Justice (ECJ) – consisting of a full chamber of 13 judges, as opposed to the customary five – has handed down a landmark decision in relation to the patentability of stem cells in Europe. The ECJ ruled that parthenotes (unfertilised human eggs which have been stimulated to divide in the absence of sperm) are not classed as “human embryos” within the meaning of the EC Biotech Directive1 (the Directive) and, therefore, can be patented.

The case drew widespread attention, most obviously in the life sciences sector, because of the importance of the decision, which has provided much needed clarity, particularly with regards to Article 6 of the Directive and the definition of “human embryo”. Article 6(1) says that inventions are not patentable where their commercial exploitation would be “contrary to ordre public or morality”. Article 6(2) proceeds to list examples of unpatentable inventions including, under Article 6(2)(c), the “uses of human embryos for industrial or commercial purposes”.

A number of previous referrals to the ECJ have requested guidance as to the meaning of “human embryo”, with the most recent decision being that in Brüstle which was undeniably ambiguous: it defined a human embryo as including: “unfertilised human ova whose division and further development have been stimulated by parthenogenesis”, because they are “capable of commencing the process of development of a human being”.

The decision in the International Stem Cell Corporation case has clarified the position, with the ECJ confirming that, in fact, parthenotes are patentable without infringing Article 6 of the Directive. It was the argued by International Stem Cell Corporation that eggs, activated through chemical parthenogenesis, could not develop into human beings as they lacked the full parental DNA required. The ECJ agreed, stating that “in order to be classified as a “human embryo”, a non-fertilised human ovum would have had to have the inherent capacity of developing into a human being”. Furthermore, it was ruled that if an egg were able to develop into an embryo “it should be treated in the same way as a fertilised human ovum, at all stages of its development”.

This decision is highly significant for companies involved in this sector (including in the field of stem cell research), as it means that they can protect the results of their research and development by patenting advances made. On a more global level, the decision is important as it aligns European law with that of the US; without it, European industry could have found itself lagging behind industry elsewhere in the world.

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